Chalazia Treatment Study (CTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Shu-Hong Chang, University of Washington
ClinicalTrials.gov Identifier:
NCT02025023
First received: December 29, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

Local injection of 5-fluorouracil into a chalazion (stye) is as effective as local injection of triamcinolone (steroid) and incision and curettage for treatment of chalazia.


Condition Intervention Phase
Chalazion
Drug: 5-fluorouracil Injection
Drug: Triamcinolone Acetonide
Procedure: Incision and Curettage
Drug: Triamcinolone Acetonide/5-fluorouracil mixture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Size of chalazion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Incision and Curettage
A vertical incision over the area of chalazion will be done. Inflammatory material will be removed and the chalazion capsule will be excised.
Procedure: Incision and Curettage
If chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture.
Active Comparator: Injection of Triamcinolone Acetonide
0.1 ml of triamcinolone is injected directly in the chalazion.
Drug: Triamcinolone Acetonide
If chalazion present at follow-up, another Triamcinolone injection will be done.
Other Name: triamcinolone
Procedure: Incision and Curettage
If chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture.
Active Comparator: Injection of 5-fluorouracil
0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.
Drug: 5-fluorouracil Injection
If the chalazion is present at follow-up visit, another injection of 5-FU will be given.
Other Name: 5-FU
Procedure: Incision and Curettage
If chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture.
Active Comparator: Injection of triamcinolone/5FU mixture
0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion.
Procedure: Incision and Curettage
If chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture.
Drug: Triamcinolone Acetonide/5-fluorouracil mixture
If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.

Detailed Description:

This is a prospective randomized interventional study comparing four current standard-of-care treatments for chalazia: incision and curettage, local injection of triamcinolone, local injection of 5-FU, and local injection of combination triamcinolone/5-FU.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Single or multiple chalazia in a single eyelid

Exclusion Criteria:

  • Chalazia present for less than one month and no previous injection or incision and curettage
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025023

Contacts
Contact: Shu-Hong Chang, MD 206-744-2020 shuchang@uw.edu
Contact: Sue Rath, COT 206-897-4331 raths@uw.edu

Locations
United States, Washington
University of Washington Eye Institute at Harborview Recruiting
Seattle, Washington, United States, 98104
Contact: Sue Rath, COT    206-897-4331    raths@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Shu-Hong Chang, MD University of Washington Eye Institute
  More Information

No publications provided

Responsible Party: Shu-Hong Chang, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02025023     History of Changes
Other Study ID Numbers: 42336-D
Study First Received: December 29, 2013
Last Updated: December 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Size
Pain
Resolution
Complications
Swelling

Additional relevant MeSH terms:
Eyelid Diseases
Chalazion
Cysts
Neoplasms
Eye Diseases
Fluorouracil
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone diacetate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014